Indonesia After Discharge LBW Infant HMF Supplementation Study

Breast Feeding, Exclusive Clinical Trial

— DAHLIA  

Official title:

Growth and Body Composition of Low Birth Weight Infants Supplemented With Human Milk Fortifier After Discharge: A Double-Blind Randomized Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04954807
• Other study ID #: 20-02-0127
• Status: Completed
• Phase: N/A
• Start date: December 8, 2020
• Est. completion date: February 25, 2022

Study information

• Verified date: March 2022
• Source: Indonesia University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Low birth weight (LBW) infant (1800-2449 gram) will be given the new human milk fortifier (HMF) which contains protein, lipid, carbohydrate and micronutrients after discharge. Human Milk Fortifier or placebo (carbohydrate only with similar calorie content) will be provided until 3 months of age. The investigators want to evaluate if the addition of HMF to mother's milk while breastfeeding LBW infants after discharge influences growth and body composition up to 3 months of age.

Description:

This is a prospective two arms parallel double-blind randomized clinical trial in LBW infants. Clinically healthy LBW infants discharge on oral feeding of human milk before 2 weeks of age (< 15 days old) will be invited to participate in the study. Exclusively or predominantly breastfed infants will be encourage to use finger feeding as method of supplementation, but mothers can choose their own preferences if they wish to do so.

After signing the informed consent by parent, subject will be randomized to one of four group. Randomization list were prepare by one investigator who do not involve in recruitment, outcome measures and statistical analysis. Study product will be labeled as A, B, C D in similar tin. Only manufacturer know the content of these tins and the code will be revealed after statistical analysis completed. Parents will be given this 200 g tin of study product and ask to return the tin after 14 days of opening. Unblinded assistant will weight the tin before and after opening to estimate the HMF intake for 14 days.

This study will be conducted in several hospitals in Greater Jakarta.

Adherence to study protocol will be encouraged during face to face session initially in dispensing study product and subsequent visits (visit 1 at one-month-old, visit 2 at two months old). These sessions will include the reminder of the importance of following study protocol, breastfeeding support if needed and discussion about difficulties that arise. The investigators will also remind mothers via text to fill in three days diary of intake one week before each visit.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 163
• Est. completion date: February 25, 2022
• Est. primary completion date: February 23, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A to 14 Days

Eligibility

Inclusion Criteria:

1. Low birth weight infants (1800-2499 g) with oral feeding

2. Exclusively breastfed or predominantly breastfed (consuming term infant formula less than 50 ml/Kg BW/day) at discharge

3. Discharge from the hospital before 2 weeks of age and maximal age of enrolment is 14 days old

4. Live in greater Jakarta

5. Parents agree in writing to study participation and indicate their intention to follow study procedures.

Exclusion Criteria:

Any subject who has major congenital anomaly or any other disorder(s) that infers with normal feeding, growth, and neurodevelopment.

Participating in another intervention trial

Related Conditions & MeSH terms

• Birth Weight
• Breast Feeding, Exclusive
• Gestational Age and Weight Conditions

Intervention

Dietary Supplement:
• human milk fortified
HMF will be given 6 scoops a day
• placebo
Placebo will be given six scoops a day

Locations

Country	Name	City	State
Indonesia	Hermina Hospital	Bekasi	Jawa Barat
Indonesia	Budi Kemuliaan Hospital	Jakarta	Central Jakarta
Indonesia	Koja District Hospital	Jakarta
Indonesia	Pasarebo Regional Hospital	Jakarta

Sponsors (2)

Lead Sponsor	Collaborator
Indonesia University	Ludwig-Maximilians - University of Munich

Country where clinical trial is conducted

Indonesia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Gaining weight	Gain in weight (g/kg initial weight & difference) between study enrolment and three months of age	three months of age
Secondary	Average weight gain	Average daily weight gain (g/kg/day) from enrolment to at three months of age	enrollment to three months of age
Secondary	Gaining length	Gain in length (mm initial length & difference) from study enrolment to the age of 3 months	Three months of age
Secondary	Head circumference	Gain in head circumference (mm initial head circumference & difference) from study enrolment to the age of 3 months	Three months of age
Secondary	Weight for age	Difference of weight for age (Z score) from study enrolment to the age of 3 months	Three months of age
Secondary	Body fat percentage	Difference in body fat percentage between groups	Three months of age
Secondary	Stool consistency	Median type of stools according to Diapered Infant stool chart between groups	enrollment to three months of age
Secondary	Stool frequency	average stool frequency per day between groups	enrollment to three months of age
Secondary	Vomit	Number of subjects who reported to have vomit between groups	enrollment to three months of age
Secondary	Bloating	Number of subjects who reported to experience bloating between groups	enrollment to three months of age
Secondary	Fever	Number of subjects who reported to experience fever between groups	enrollment to three months of age
Secondary	Rehospitalization	Number of subjects who reported being hospitalized between groups	enrollment to three months of age